Neural Effects of Cognitive-behaviour Therapy in Panic Disorder

Panic Disorder Clinical Trial

Official title:

Neural Effects of Cognitive-behaviour Therapy in Panic Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03251235
• Other study ID #: 09/H0604/55
• Status: Completed
• Phase: N/A
• First received: July 31, 2017
• Last updated: August 11, 2017
• Start date: January 1, 2011
• Est. completion date: February 1, 2016

Study information

• Verified date: August 2017
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Exposure-based cognitive-behaviour therapy (CBT) for anxiety disorders is an effective intervention, but the brain mechanisms driving recovery are largely unknown. In this experimental medicine study, it will be investigated to what degree CBT affects neural markers of anxiety at an early stage of treatment, to identify dynamic mechanistic changes which might be crucial in the process of recovery as opposed to those seen following full treatment completion. Patients with panic disorder will be recruited and randomly allocated to a group receiving 4 weekly sessions of cognitive-behaviour therapy versus a waiting group not receiving any interventions until after the experimental procedure.

Description:

PURPOSE The primary purpose is to enhance our understanding of the mechanisms essential in effective treatment of panic disorder.

METHODS Design: The present study has a between−subjects design, including a waiting group of participants with panic symptoms and a treatment group of participants with panic symptoms who will receive cognitive−behavioural treatment before being tested.

Participants: Twenty-eight volunteers with panic symptoms will be recruited. For participants who do meet the basic study criteria a phone screening appointment (10 − 30 mins) will be arranged to further screen for relevant inclusion and exclusion criteria. They will then be invited to the Department of Psychiatry for the pre−assessment session.

Treatment: Within the study, the investigators will offer participants a brief CBT course of 4 sessions, offered by the Lupina service. The Lupina Service forms part of the OBMH primary care Counselling & Psychology Service, based at the Warneford Hospital. It provides intensive individual CBT for panic disorder and agoraphobia and is staffed by trained graduate volunteer therapists. Potential therapists are psychology graduates with prior mental health experience, who are given 2 days' intensive training in CBT for panic disorder and agoraphobia by Alison Croft, Consultant Clinical Psychologist. They then receive group supervision of their clinical cases. Service evaluation indicates equivalent clinical outcomes for volunteer therapists relative to qualified clinical psychologists.

Procedure: Participants will be randomly allocated to either the treatment group or the waiting group. On arrival to the pre−assessment session, participants will be given a copy of the information sheet (previously seen during the online screening and e−mailed/ posted to them). They will be invited to fill out the consent form. Screening for past or previous psychiatric illness will be achieved using a structured clinical interview (SCID). In addition, participants will be asked to complete a battery of questionnaires. They will also be familiarised with the procedure occurring on the scanning day. Any outstanding questions the participant has will be addressed. The visit lasts about 1 to 1 ½ hrs. After the pre−assessment, a 4 weeks follow−up appointment (post−assessment) will be arranged with all participants. Half of the participants will be referred for treatment in the LUPINA group during that time. At the post−assessment 4 weeks later, the participants will be asked to come to the OCMR (Oxford Clinical Resonance Imaging) Department at the John Radcliffe Hospital. The visit will last a total of 2½ to 3 hrs and include a scanning session lasting 1 to 1 ½ hrs. Subjective mood will be assessed on the day of the scan using the State form of the State−Trait Anxiety Inventory, a Mood Visual Analogue Scale and the Positive and Negative Affect Schedule. In addition, subjects will again complete the questionnaires from the pre−assessment. After the scan, participants will work on two behavioural computer tasks using emotional faces and word stimuli to assess facial recognition and attention outside the scanner. At the end of the session, patients from the waiting group will be offered the taster−CBT treatment within the LUPINA service.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: February 1, 2016
• Est. primary completion date: September 4, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Aged 18-70

• Sufficiently fluent in English to understand the task and instructions

• PDSS score of at least 6

• At least two full panic attacks or limited symptoms attacks last 4 weeks

Exclusion Criteria:

• CNS-acting medication (antidepressants within last 6 months, benzodiazepine last 3 days)

• Current or past history of alcohol/ drug abuse

• Serious medical conditions (e.g., epilepsy, heart or respiratory problems)

• Done the task before

• Waiting group: under current psychotherapeutic treatment

• Pregnancy

• Contraindications to MRI e.g. pacemaker, mechanical heart valve, hip replacement, metal implants

• Severe claustrophobia that limits ability to participate in fMRI scanning

Related Conditions & MeSH terms

• Disease
• Panic Disorder

Intervention

Behavioral:
• Cognitive Behaviour Therapy

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Oxford

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Emotional processing	Activation levels in the fear circuit of the brain in response to emotional stimuli (fMRI)	Treatment Group: post 4-week CBT treatment, waiting Group: post 4-week waiting
Secondary	Clinical symptom severity - Global anxiety and depression (self-report)	Hamilton Anxiety and Depression Scale HADS	Baseline, after 4 weeks treatment/ waiting
Secondary	Clinical symptom severity - Fear of physical sensations (self-report)	Body Sensations Questionnaire BSQ	Baseline, after 4 weeks treatment/ waiting
Secondary	Clinical symptom severity - Agoraphobic fear (self-report)	Agoraphobic Cognitions Questionnaire ACQ	Baseline, after 4 weeks treatment/ waiting
Secondary	Clinical symptom severity - Clinical severity and improvement (clinician-report)	Clinical Global Impression Scale CGI	Baseline, after 4 weeks treatment/ waiting